The Efficacy of Guided Tissue Regeneration With Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane: a Randomized Controlled Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2025-01-01

Brief Summary

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The most commonly used barrier membrane material in guided tissue regeneration is absorbable collagen membrane. Although the collagen membrane has a good barrier effect, it lacks the growth factors needed for periodontal tissue regeneration, which affects the effect of collagen membrane on periodontal tissue regeneration. Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane is a novel absorbable membrane that retains the extracellular matrix structure and is conducive to vascular ingrowth and tissue repair. The in vitro study showed that SIS membrane had excellent biocompatibility and certain antibacterial effect. Preclinical study also showed that SIS membrane significantly promoted the differentiation of bone marrow mesenchymal stem cells into osteoblasts, and promoted bone regeneration more effectively than collagen mechanism materials. SIS membrane can be used in soft tissue wound repair, guided bone regeneration, site preservation and other surgeries, and has achieved good therapeutic effects. However, whether the application of SIS membrane can achieve good therapeutic effect on periodontal guide tissue regeneration is still unclear. Therefore, in this study, the effects of guide tissue regeneration with collagen membrane and SIS membrane were compared through a randomized controlled clinical study.

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Detailed Description

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Conditions

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Guided Tissue Regeneration Extracellular Matrix Scaffold of Small Intestinal Submucosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Small Intestinal Submucosa Membrane

Group Type EXPERIMENTAL

Flap surgery+bone graft+guided tissue regeneration

Intervention Type PROCEDURE

after flap elevation and debridement, intrabony defect was filled with Bio-Oss and covered with membrane.

Bio-guide

Group Type ACTIVE_COMPARATOR

Flap surgery+bone graft+guided tissue regeneration

Intervention Type PROCEDURE

after flap elevation and debridement, intrabony defect was filled with Bio-Oss and covered with membrane.

Interventions

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Flap surgery+bone graft+guided tissue regeneration

after flap elevation and debridement, intrabony defect was filled with Bio-Oss and covered with membrane.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* periodontitis patients with stage III to IV, grade C had one or more intrabony defects with a depth of ≥3 mm; PD≥5mm after initial periodontal therapy.